XerostomiaPhase 1NCT06392711
Dose-Escalation Trial of Mesenchymal Stromal Cells in Patients With Medical Xerostomia
A Phase 1 study testing Mesenchymal Stromal Cells (MSC) Dose Level 0 and Mesenchymal Stromal Cells (MSC) Dose Level 1 in people with Xerostomia and Graft-versus-host-disease, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The goal of this clinical trial is to evaluate the safety and tolerability of injecting certain cells produced in bone marrow called mesenchymal stromal cells (MSCs) into salivary glands. The main question it aims to answer is whether injection of MSCs into salivary glands results in any improvement in dry mouth. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Xerostomia, Graft-versus-host-disease, Sjogren's Disease
- What is being tested?
- Mesenchymal Stromal Cells (MSC) Dose Level 0 and Mesenchymal Stromal Cells (MSC) Dose Level 1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2024to Nov 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Xerostomia, defined as an unstimulated salivary flow <1.2 mL in 5 minutes documented at any time following xerostomia diagnosis and prior to enrollment
- Xerostomia not resulting from radiotherapy (medical xerostomia)
- ≥ 18 years of age, ≤ 90 years of age
- Karnofsky performance status ≥ 70, patient eligible for bone marrow aspirate with wakeful anesthesia
- Willing and able to give informed consent
- Radiographically confirmed bilateral submandibular glands
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- If female of childbearing potential, negative pregnancy test
- Males and females of childbearing potential willing to use acceptable contraception
- Laboratory Values (within 28 calendar days of enrollment):
- Hgb ≥ 9 g/dL (5.58 mmol/L)
- Platelets ≥ 100,000/µL
- ANC ≥ 1000/µL
- Lymphocytes ≥ 800/µL
- PT/INR and PTT within normal limits based on age/sex
Who cannot join
- Patients with one submandibular gland
- Sialolithiasis
- Poorly-controlled diabetes mellitus (HbA1c ≥ 7%)
- Patients who initiated any diuretic therapy before developing dry mouth symptoms and are still on diuretic therapy and the referring provider believes the dryness symptoms are driven by diuretic use
- Untreated oral candidiasis based on physical exam at enrollment
- Malignancy within the last 2 years (except adequately treated stage I lung cancer, low risk prostate cancer that has been treated or is undergoing active surveillance, adequately treated non-melanoma skin cancer, adequately treated DCIS, or adequately treated stage I cervical cancer)
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- For patients on immunosuppressive therapy, must be on stable dose of immunosuppressive therapy for at least 2 months, allowing for dose adjustments for blood levels of drugs
- Transfusion dependency
- Life expectancy ≤ 6 months as determined by the investigator
- Use of investigational drugs, biologics, or devices within 30 calendar days prior to enrollment
- Pregnant or lactating women or those who plan to become pregnant during the study
- Not suitable for study participation due to other reasons at discretion of investigators.
- Enrollment in another clinical study possibly interfering with the endpoints of this study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Wisconsin
Madison, Wisconsin, 53705
Cancer Connect, 800-622-8922, clinicaltrials@cancer.wisc.edu
About this study
Official title: UW23129: A Phase I Dose-Escalation Trial of Mesenchymal Stromal Cells in Patients With Medical Xerostomia
The goal of this clinical trial is to evaluate the safety and tolerability of injecting certain cells produced in bone marrow called mesenchymal stromal cells (MSCs) into salivary glands. The main question it aims to answer is whether injection of MSCs into salivary glands results in any improvement in dry mouth.
Participants will:
- have bone marrow collected using a needle
- undergo a salivary gland ultrasound
- complete questionnaires
- receive an injection of the bone marrow cells into a salivary gland
Read the detailed description
This single-center phase I dose-escalation with expansion cohort, open label, non-randomized, non-placebo controlled, single group assignment study will assess the safety and tolerability of mesenchymal stromal cells (MSCs) for treatment of xerostomia, focusing on xerostomia with inflammatory etiology (e.g., Sjögren's disease [SjD], graft-versus-host disease [GVHD]). An initial cohort of subjects (n=6) will receive a unilateral injection of MSCs at dose level 0. If unilateral treatment is tolerated, a dose escalation cohort (n=8-18) will receive bilateral injection of MSCs. Dose escalation will proceed using a standard 3+3 design and once the recommended phase II dose (RP2D) is defined, 12 additional patients will be accrued to the expansion phase.
Following the completion of screening/baseline procedures, eligible participants will undergo bone marrow aspiration in order to obtain MSCs.
The MSC investigational product will be injected into one or both submandibular glands under local anesthesia at the interventional visit.
There is no expanded access program available per this protocol.
- Conditions
- Xerostomia, Graft-versus-host-disease, Sjogren's Disease
- Being tested
- Mesenchymal Stromal Cells (MSC) Dose Level 0, Mesenchymal Stromal Cells (MSC) Dose Level 1
- Medical subject headings
- Xerostomia, Graft vs Host Disease, Sjogren's Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesenchymal Stromal Cells (MSC) Dose Level 0Biological
10 (8-12) x 10^6 MSCs
Mesenchymal Stromal Cells (MSC) Dose Level 1Biological
20 (16-24) x 10^6
| Study group | Role | What they receive |
|---|---|---|
| MSCs Dose Level 0 into one submandibular gland | Active comparator | 6 subjects will receive Mesenchymal Stromal Cells (MSC) at Dose Level 0, which is 10 (8-12) x10^6 MSCs in a single submandibular gland. If this dose is deemed tolerable when injected into a single submandibular gland, this dose will be administered to both submandibular glands in the initial subjects in the dose escalation arm. Receives: Biological: Mesenchymal Stromal Cells (MSC) Dose Level 0 |
| MSCs into both submandibular glands - Dose Escalation Cohort | Active comparator | 8-18 subjects in the Dose Escalation phase of study will receive MSCs into both submandibular glands. The initial subjects in this cohort will receive Dose Level 0: 10 (8-12) x10^6 MSCs/gland. If this dose is tolerated, subsequent subjects will receive Dose Level 1: 20 (16-24) x10^6 MSCs/gland. The highest tolerated dose (recommended phase II dose or RP2D) will be administered to the subjects in the Expansion Cohort. Receives: Biological: Mesenchymal Stromal Cells (MSC) Dose Level 0; Biological: Mesenchymal Stromal Cells (MSC) Dose Level 1 |
| MSCs into both submandibular glands - Expansion Cohort | Active comparator | 12 subjects in Expansion Cohort will receive MSCs into both submandibular glands at the RP2D. Receives: Biological: Mesenchymal Stromal Cells (MSC) Dose Level 0; Biological: Mesenchymal Stromal Cells (MSC) Dose Level 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants experiencing DLT of submandibular pain
Recommended phase II dose (RP2D) will be determined by the proportion of subjects experiencing the dose-limiting toxicity (DLT) of submandibular pain > 5 on a standard 10-point pain scale of 0-10 at 1-month after MSC injection
Measured: 1 month post-injection
Proportion of participants experiencing DLT as serious adverse events (AEs)
RP2D will be determined by the proportion of subjects experiencing the dose-limiting toxicity (DLT) of any serious AE within one-month post-injection
Measured: 1 month post-injection
Proportion of participants experiencing DLT as pre-specified toxicities
RP2D will be determined by the proportion of subjects experiencing the dose-limiting toxicity (DLT) of any selected toxicity that is specified in the protocol within one-month post-injection
Measured: 1 month post-injection
Secondary outcomes (6)
Change in xerostomia scores
Xerostomia will be assessed by quality of life xerostomia (XeQoL) scores. XeQoL is a 15-item questionnaire, where items 1-14 are scored as: 0=not at all; 1=a little; 2=somewhat; 3=quite a bit; 4=very much. Item 15 is scored as: 0=delighted; 1=mostly satisfied; 2=mixed: equally satisfied/dissatisfied; 3= mostly dissatisfied; 4=terrible. Lower scores indicate less impact of mouth/throat dryness on QoL, and higher scores indicate great impact on QoL.
Measured: Baseline to 24 months
Change in salivary function-rate of salivary production
Salivary function determined by measurement of salivary production (g/5 minutes); Unstimulated saliva production will be measured by participants allowing saliva to pool in the mouth over a 5 minute period, then gently guiding saliva into a saliva collection aid; Simulated saliva production will be measured by participants chewing inert gum base to the pace of a metronome (70 beats/minute) while expectorating saliva into a saliva collection aid for 5 minutes. Cryovials containing saliva will be weighed before and after saliva collection and the difference in weight (g) will represent the amount of saliva produced in 5 minutes for each condition.
Measured: Baseline, 1 month, 3 months, 6 months, 12 months, and 24 months
Change in salivary function-saliva composition
Salivary function determined by compositional analysis of saliva sample - amylase (mU/mL). Low in disease, hypothesized to increase with intervention.
Measured: Baseline, 1 month, 3 months, 6 months, 12 months, and 24 months
Change in salivary function-saliva composition
Salivary function determined by compositional analysis of saliva sample - mucins (MUC5B in mU/mL) assessed using ELISA. Low in disease, hypothesized to increase with intervention.
Measured: Baseline, 1 month, 3 months, 6 months, 12 months, and 24 months
Change in salivary function-saliva composition
Salivary function determined by compositional analysis of saliva sample; pH assessed using pH meter. Low in disease, hypothesized to increase with intervention.
Measured: Baseline, 1 month, 3 months, 6 months, 12 months, and 24 months
Change in salivary function-saliva composition
Salivary function determined by compositional analysis of saliva sample - total protein (mg/mL). High levels in disease, hypothesized to decrease with intervention.
Measured: Baseline, 1 month, 3 months, 6 months, 12 months, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start4 Oct 2024
- Primary completionNov 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for XerostomiaStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhubin Gahvari, MD, MS, Principal investigator, University of Wisconsin, MadisonJacques Galipeau, MD, Study director, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06392711
- Sponsor's protocol ID
- 2024-0386
- Other IDs
- A534290, SMPH/MEDICINE/RHEUMATOL, UW23129, Protocol Version 11/29/25
- Status last verified
- Jun 2026
- First submitted
- 25 Apr 2024
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UW23129: A Phase I Dose-Escalation Trial of Mesenchymal Stromal Cells in Patients With Medical Xerostomia
- ClinicalTrials.gov ID
- NCT06392711
- Acronym / sponsor ID
- 2024-0386
- Conditions
- Xerostomia, Graft-versus-host-disease, Sjogren's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 4 Oct 2024 (actual)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 30 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate the safety and tolerability of injecting certain cells produced in bone marrow called mesenchymal stromal cells (MSCs) into salivary glands. The main question it aims to answer is whether injection of MSCs into salivary glands results in any improvement in dry mouth.
Participants will:
- have bone marrow collected using a needle
- undergo a salivary gland ultrasound
- complete questionnaires
- receive an injection of the bone marrow cells into a salivary gland
Detailed description
This single-center phase I dose-escalation with expansion cohort, open label, non-randomized, non-placebo controlled, single group assignment study will assess the safety and tolerability of mesenchymal stromal cells (MSCs) for treatment of xerostomia, focusing on xerostomia with inflammatory etiology (e.g., Sjögren's disease [SjD], graft-versus-host disease [GVHD]). An initial cohort of subjects (n=6) will receive a unilateral injection of MSCs at dose level 0. If unilateral treatment is tolerated, a dose escalation cohort (n=8-18) will receive bilateral injection of MSCs. Dose escalation will proceed using a standard 3+3 design and once the recommended phase II dose (RP2D) is defined, 12 additional patients will be accrued to the expansion phase.
Following the completion of screening/baseline procedures, eligible participants will undergo bone marrow aspiration in order to obtain MSCs.
The MSC investigational product will be injected into one or both submandibular glands under local anesthesia at the interventional visit.
There is no expanded access program available per this protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MSCs Dose Level 0 into one submandibular gland | Active comparator | Biological: Mesenchymal Stromal Cells (MSC) Dose Level 06 subjects will receive Mesenchymal Stromal Cells (MSC) at Dose Level 0, which is 10 (8-12) x10^6 MSCs in a single submandibular gland. If this dose is deemed tolerable when injected into a single submandibular gland, this dose will be administered to both submandibular glands in the initial subjects in the dose escalation arm. |
| MSCs into both submandibular glands - Dose Escalation Cohort | Active comparator | Biological: Mesenchymal Stromal Cells (MSC) Dose Level 0, Biological: Mesenchymal Stromal Cells (MSC) Dose Level 18-18 subjects in the Dose Escalation phase of study will receive MSCs into both submandibular glands. The initial subjects in this cohort will receive Dose Level 0: 10 (8-12) x10^6 MSCs/gland. If this dose is tolerated, subsequent subjects will receive Dose Level 1: 20 (16-24) x10^6 MSCs/gland. The highest tolerated dose (recommended phase II dose or RP2D) will be administered to the subjects in the Expansion Cohort. |
| MSCs into both submandibular glands - Expansion Cohort | Active comparator | Biological: Mesenchymal Stromal Cells (MSC) Dose Level 0, Biological: Mesenchymal Stromal Cells (MSC) Dose Level 112 subjects in Expansion Cohort will receive MSCs into both submandibular glands at the RP2D. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Xerostomia, defined as an unstimulated salivary flow <1.2 mL in 5 minutes documented at any time following xerostomia diagnosis and prior to enrollment
- Xerostomia not resulting from radiotherapy (medical xerostomia)
- ≥ 18 years of age, ≤ 90 years of age
- Karnofsky performance status ≥ 70, patient eligible for bone marrow aspirate with wakeful anesthesia
- Willing and able to give informed consent
Key exclusion criteria (13 listed)
- Patients with one submandibular gland
- Sialolithiasis
- Poorly-controlled diabetes mellitus (HbA1c ≥ 7%)
- Patients who initiated any diuretic therapy before developing dry mouth symptoms and are still on diuretic therapy and the referring provider believes the dryness symptoms are driven by diuretic use
- Untreated oral candidiasis based on physical exam at enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mesenchymal Stromal Cells (MSC) Dose Level 010 (8-12) x 10^6 MSCs | Biological | MSCs Dose Level 0 into one submandibular gland, MSCs into both submandibular glands - Dose Escalation Cohort, MSCs into both submandibular glands - Expansion Cohort |
| Mesenchymal Stromal Cells (MSC) Dose Level 120 (16-24) x 10^6 | Biological | MSCs into both submandibular glands - Dose Escalation Cohort, MSCs into both submandibular glands - Expansion Cohort |
Primary outcome
Proportion of participants experiencing DLT of submandibular pain
Time frame: 1 month post-injection
Recommended phase II dose (RP2D) will be determined by the proportion of subjects experiencing the dose-limiting toxicity (DLT) of submandibular pain > 5 on a standard 10-point pain scale of 0-10 at 1-month after MSC injection
Proportion of participants experiencing DLT as serious adverse events (AEs)
Time frame: 1 month post-injection
RP2D will be determined by the proportion of subjects experiencing the dose-limiting toxicity (DLT) of any serious AE within one-month post-injection
Proportion of participants experiencing DLT as pre-specified toxicities
Time frame: 1 month post-injection
RP2D will be determined by the proportion of subjects experiencing the dose-limiting toxicity (DLT) of any selected toxicity that is specified in the protocol within one-month post-injection
6 secondary outcomes
Change in xerostomia scores
Time frame: Baseline to 24 months
Change in salivary function-rate of salivary production
Time frame: Baseline, 1 month, 3 months, 6 months, 12 months, and 24 months
Change in salivary function-saliva composition
Time frame: Baseline, 1 month, 3 months, 6 months, 12 months, and 24 months
Change in salivary function-saliva composition
Time frame: Baseline, 1 month, 3 months, 6 months, 12 months, and 24 months
Change in salivary function-saliva composition
Time frame: Baseline, 1 month, 3 months, 6 months, 12 months, and 24 months
Change in salivary function-saliva composition
Time frame: Baseline, 1 month, 3 months, 6 months, 12 months, and 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhubin Gahvari, MD, MS principal investigator
University of Wisconsin, Madison
Jacques Galipeau, MD study director
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Mesenchymal Stromal Cells (MSC) Dose Level 0 and Mesenchymal Stromal Cells (MSC) Dose Level 1 in people with Xerostomia and Graft-versus-host-disease, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cancer Connect (800-622-8922, clinicaltrials@cancer.wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants experiencing DLT of submandibular pain (time frame: 1 month post-injection). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.